BridgeMD
TRI-AB trial
EU CTIS ID: 2024-520251-24-00
What this study is testing
To assess whether tablet pivmecillinam 800 mg three times daily combined with a single iv dose of gentamicin 5 mg/kg is non-inferior to current standard empirical treatments (iv ampicillin plus gentamicin or iv piperacillin/tazobactam) for achieving clinical cure on day 3 in hospitalised adults with cUTI
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥18 years
- Hospitalised with symptoms and/or signs of acute pyelonephritis or lower cUTI
- Empirical intravenous antibiotic treatment is planned by the treating physician
You likely can't join if
- quick Sequential Organ Failure Assessment Score (qSOFA) ≥2 (qSOFA score allocates one point for each of the following criteria: respiratory rate ≥22/min, altered mental status, and systolic blood pressure ≤100 mmHg)
- Known myasthenia gravis
- Acute mononucleosis or porphyria
- Pre-existing complicated urogenital conditions
- Current or earlier treatment with cisplatin and/or carboplatin
- Descent from the Faroe Islands without prior negative screening for Carnitine Transporter Deficiency (CTD)
See the full eligibility criteria
- Age ≥18 years
- Hospitalised with symptoms and/or signs of acute pyelonephritis or lower cUTI
- Empirical intravenous antibiotic treatment is planned by the treating physician
- quick Sequential Organ Failure Assessment Score (qSOFA) ≥2 (qSOFA score allocates one point for each of the following criteria: respiratory rate ≥22/min, altered mental status, and systolic blood pressure ≤100 mmHg)
- Known myasthenia gravis
- Acute mononucleosis or porphyria
- Pre-existing complicated urogenital conditions
- Current or earlier treatment with cisplatin and/or carboplatin
- Descent from the Faroe Islands without prior negative screening for Carnitine Transporter Deficiency (CTD)
- Receipt of iv antibiotics covering cUTI prior to enrollment
- Kidney transplant recipients or patients on hemodialysis or periotoneal dialysis
- Informed consent prior to inclusion unobtainable.
- estimated Glomerular Filtration Rate <30ml/min/1.73m^2
- Urine culture within 72 hours showing a microorganism resistant to one of the study regimens
- Known allergy or hypersensitivity to pivmecillinam, penicillins, cephalosporins, aminoglycosides or excipients
- Pregnancy or breastfeeding
- Inability to ingest oral medication
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.